Sunlite Plastics is a custom extrusion company that specializes in high volume, tight tolerance, flexible medical tubing. We also compound PVC materials for our own use. Sunlite’s customers include many of the most highly regarded medical device OEMs in the world.We are looking for a Manufacturing Engineer to join our growing team. The Manufacturing Engineer will support all manufacturing groups by maintaining and improving existing processes to meet all Sunlite quality goals and customer needs. He/She will work with Mfg. Process Engineers and Maintenance personnel to evaluate performance and create solutions to improve processes and equipment while promoting safety.

Essential Job Duties and Responsibilities

• Process Development
  • Assist in development, testing and improve manufacturing processes for new and existing products that will reduce operating costs, reduce labor, reduce product variability and increase yields.
  • Assist in planning, coordinating, developing and executing test protocols, experiments, process characterization and process validations (IQ, OQ, PQ) on new and revised products and processes.
  • Assist in writing and updating standard operating procedures. Work with operators to document their processes, study the operations and work practices for improvements, and document findings.
• Manufacturing Operations Support
  • Support internal customers including but not limited to Manufacturing, Sales, Quality and others as necessary.
  • Provide timely resolution of product, process and equipment problems in the form of creative short and long term solutions.
  • Assist in technical support and troubleshooting for manufacturing and extrusion operations.
  • Monitor manufacturing variances so that problem solving and improvement opportunities are identified. Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
  • Quantify process improvements in terms of additional throughput, ergonomics, reduction in non-value added activity, set up reduction time, and quality improvements.
  • Research and develop proposals for new equipment and machinery. Prepare cost justifications and payback analysis. Contract with outside services firms for machine installation and set-up.
  • Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service.
• QA/RA
  • Stay current with and ensure appropriate QA/RA SOP’s are followed on all projects, including: product/process development process, process controls, process validations, and ECO system.
  • Provide support as required to GMP, safety, ISO and internal audits.
• Other
  • May perform other duties as assigned

Education and Experience

• Must be legally authorized to work in the United States full-time without sponsorship at time of hire.
• Bachelors Level of Degree in Engineering.
• Work experience with knowledge of ISO13485 and cGMP regulations preferred.
• Self-starter with the ability to prioritize, take ownership and deliver results against challenging performance indicators
• Ability to thrive in a fast-paced environment and communicate effectively across all levels of the organization
• Knowledge of statistics and process control tools and Integrated Lean Six Sigma Work Systems strongly preferred although not essential as training will be provided internally
• Knowledge of machining skills would be a plus
• Ability to work off shifts and weekends as needed by the business
• Authorized to work in the US without sponsorship